MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS RIGHT 11X160MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: medical products: blunt tip screw 4x48mm; catalog#: 47-2486-048-40; lot#: 3008269.Blunt tip screw 4x42mm; catalog#: 47-2486-042-40; lot#: 3024693.Blunt tip screw 4x44mm; catalog#: 47-2486-044-40; lot#: 3006464.Blunt tip screw 4x65mm; catalog#: 47-2486-065-40; lot#: 3024760.Cortical bone screw 4x34mm; catalog#: 47-2486-134-40; lot#: 3008285.Cortical bone screw 4x34mm; catalog#: 47-2486-134-40; lot#: 3024393.Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3025177.Therapy date: (b)(6) 2021.Review of event description: it was reported that the patient underwent implantation on (b)(6) 2021.6 weeks post implantation, it was found that one of the screw has backed out.Subsequently a revision has taken place on (b)(6) 2021 during which only the 3rd screw that backed out was explanted.The surgeon was able to remove the screw without loosening the corelock.The corelock mechanism was engaged with a non-torque limiting driver after placing all the interlocking screws.Review of received data: due diligence: no further "due diligence" required as all required information to support the conclusion is available or was already requested.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing with a potential correlation to the reported event.Surgical technique: the surgical technique 197-glbl-en explains that the locking of the corelock is done using the corelock driver with torque limiting handle."turn slowly clockwise to tighten and engage the corelock mechanism until a click is felt from the torque limiting handle." conclusion: it was reported that the patient underwent implantation on (b)(6) 2021.6 weeks post implantation, it was found that one of the screw has backed out.Subsequently a revision has taken place on (b)(6) 2021 during which only the 3rd screw that backed out was explanted.The surgeon was able to remove the screw without loosening the corelock.The corelock mechanism was engaged with a non-torque limiting driver after placing all the interlocking screws.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Neither x-rays, operative notes, office visit notes, nor devices or photos of the devices were received; therefore the condition of the components are unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Based on the investigation the reported event cannot be confirmed.The locking of the corelock during implantation has not been performed as specified in the surgical technique using only the corelock driver with torque limiting handle.Instead, a non-torque limiting screwdriver was used.It remains unknown what the potential effect of this deviation from the surgical technique could be and if this may have potentially contributed to the revision surgery.Based on the investigation it can only be assumed that the potential migration of the screw might be multifactorial related to either patient condition and behaviour, implantation procedure or design features.If and to what extent any of these aspects may have influenced the backing out of the screw remains unknown.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.The need for corrective measures is not indicated for the time being and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Patient was implanted with ann on unknown side.Six weeks post surgery it was found that one of the screw was backed out and hence revision surgery was performed during which only the 3rd screw that backed out was explanted.The surgeon was able to remove the screw without loosening the corelock.

• Brand Name: PROXIMAL HUMERUS RIGHT 11X160MM
• Type of Device: AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12488957
• MDR Text Key: 271946469
• Report Number: 0009613350-2021-00477
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505483
• UDI-Public: 00889024505483
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2496-160-11
• Device Lot Number: 3031558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention